FDA – The Rest of the Story

The 12,000-employee FDA regulates products that account for more than $1.5 trillion in yearly sales, or about a 10th of the US economy. Besides food and drug safety, the agency also enforces regulations covering medical devices and cosmetics.

The FDA is part of the executive branch of government and therefore, any filing of reports by companies where critically important safety data is willfully omitted is a criminal offense under US Code: 18 USC 1001- Fraud and False Statements, according to Barry Turner, a professor of law and medical ethics in the UK.

Mr Turner explains that concealing dangerous side effects is a willfully misleading act and that any company that engages in a course of action that involves withholding data about adverse reactions is committing a crime.

However, in order to find a company guilty of fraud, there would probably have to be a showing that FDA officials were not involved in the underlying act, and this is where the whole case would fall apart because Big Pharma has so successfully infiltrated the nation’s top regulatory agency that there are no “clean hands” so to speak.

Since the Bush administration took over the FDA, there has been several unsuitable Commissioners. Mark McClellan was the official leader in 2003, but after being embarrassed on 60 Minutes when asked why Canadian drugs were not safe enough to be imported for use by Americans, he moved on to a less visible position.

After that, Lester Crawford served as Acting Commissioner until his nomination for full-time Commissioner was approved in August 2005. However, Mr Crawford’s tenure was also short-lived and he abruptly resigned two months after he was confirmed.

About a year later, on October 2006, Mr Crawford pleaded guilty to charges of having a conflict of interest and false reporting of information about his stock holdings with pharmaceutical companies during the years he was employed at the FDA. Going back to 2002, investigators found that Mr Crawford had filed 7 false reports with the government ethics office and Congress.

Last month, on February 27, 2007, Judge Deborah Robinson, sentenced Mr Crawford to three years of supervised probation, 50 hours of community service, plus fines of roughly $90,000 for lying about the stocks that he and his wife owned in companies that were regulated by the FDA.

The judge would not agree to let Mr Crawford off the hook as easily as proposed. “While the total fine exceeds what the parties agreed to,” she said at the hearing, “the fine is well below the maximum under the statute.”

The Bush administration’s original nomination of Mr Crawford was nearly derailed a number of times. On July 18, 2005, a member of the administration’s own party, Senator Charles Grassley (R-Iowa) took to the Senate floor to respond to the nomination and gave a caustic critique of the FDA as a whole and Crawford’s conduct specifically.

“My oversight of the FDA,” he stated, “leads me to the conclusion that there are cultural and systemic problems at the FDA.”

“Unfortunately,” he said, “Dr. Crawford has long been part of that same culture and system.” Senator Grassley also elaborated further in stating:

“During Dr. Crawford’s tenure, I have witnessed the suppression of the scientific process and the muzzling of scientific dissent. First, with Dr. Mosholder finding a link between anti-depressants, children and suicide. And second with Dr. Graham’s allegations regarding the FDA, Vioxx and post-marketing safety generally. Dr. Graham’s testimony before the Finance Committee suggests that the problems are systemic.

“Oversight of the FDA exposed the cozy relationship that exists between the FDA and the drug industry. It revealed that the FDA negotiated for almost two years with Merck about how to change the Vioxx label so people would know about the risk of heart attacks.”

The evidence is overwhelming, Senator Grassley said, that the FDA must change to better protect the people. “Dr. Crawford,” he stated, “does not appear willing to be the man to change the FDA.”

A few months earlier, several Democrats had also raised strong objections to the nomination. On April 6, 2005, following a closed-door meeting, Senators Patty Murray (D-Wash) and Hillary Rodham Clinton (D-NY), members of the Senate Health Education and Labor Committee, announced their intention to place a “hold” on Dr Crawford’s nomination, citing the FDA’s failure to act on a host of public health issues, including the Plan B contraceptive approval, during his tenure as Acting Commissioner.

On June 15, 2005, Senators Murray and Clinton delayed consideration of the nomination by the full Senate. “At a time when the FDA needs a strong leader to restore its reputation,” Senator Clinton said in a statement, “I fear that Dr. Crawford’s record demonstrates a lack of vision and drive to ensure that the FDA upholds its gold standard of drug regulation.”

“He has failed,” she explained, “to address the concerns raised by his own employees about the needs of the agency.”

“And he cannot provide assurances,” she continued, “that the FDA will make science, not ideology or other interests, the cornerstone of its decision making.”

“The Senators’ hold will remain,” the statement said, “in effect until FDA issues a yes or no decision on the over-the-counter application of Plan B emergency contraceptives.”

“We are asking FDA to explain,” they Senators stated, “why they are delaying an over-the-counter application for Plan B that even their own Advisory Panel overwhelmingly recommended for approval.”

“I fear that the case of Plan B,” Senator Murray noted, “highlights a leadership problem at FDA – a leadership that can be biased or open to undue influence.”

On July 15, 2005, Senators Clinton and Murray lifted the hold after receiving assurance from Health and Human Services Secretary, Mike Leavitt, that the FDA would act on the Plan B application by September 1, 2005.

Once the nomination was confirmed, that assurance turned out to be meaningless and September 1, came and went. However, 23 days later, Dr Crawford resigned after serving only two months as Commissioner, and Andrew von Eschenbach became the Acting Commissioner.

The emergency contraceptive at the center of the controversy, Plan B, had been available with a prescription since 1999. In 2003, Barr Laboratories sought FDA approval to sell it over-the-counter, arguing that it could reduce the number of unintended pregnancies and abortions as an emergency contraceptive to be used within 72 hours of unprotected sex.

On May 6, 2004, Mr Crawford rejected a 23 to 4 vote by the FDA’s Advisory Committee for Reproductive Health Drugs to approve over-the-counter sale of Plan B, in effect overruling a scientific consensus that overwhelmingly found the drug safe and effective.

At the time, critics accused FDA officials of ignoring scientific evidence due to pressure from social conservatives, and they of course denied the allegations.

However, much of the outrage that erupted a year later when it came time for Mr Crawford’s confirmation as Commissioner, was fueled by Dr David Hager, an obstetrician-gynecologist, and a Bush appointee to the FDA Advisory Committee, who was known to be one of the 4 members that voted against the approval of Plan B.

In 2002, the original appointment of Dr Hager was for chairman of the Advisory Committee. However, the nomination drew an onslaught of protests due to his ideological views such as refusing to prescribe contraceptives to unmarried women and advocating the use of prayer for the relief of premenstrual syndrome.

Critics said they objected to Dr Hager holding a position where he could have an impact on decisions affecting women’s health, and finally to put an end to the controversy, the administration announced that Dr Hager would serve on the committee but not as chairman.

In May 2005, the media began reporting that after the Committee voted to approve Plan B, the FDA had asked Dr Hager to write a minority opinion advocating against the recommendation and submit it to Dr Crawford.

On May 12, 2005, the Washington Post, quoted a sermon given by Dr Hager at Asbury College in Kentucky, in which Dr Hager discussed his part in the FDA’s decision to reject the advisory panel’s recommendation.

“I was asked,” he stated, “to write a minority opinion that was sent to the commissioner of the FDA.”

“For only the second time in five decades,” Dr Hager said, “the FDA did not abide by its advisory committee opinion, and the measure was rejected.”

“I argued from a scientific perspective, and God took that information, and he used it through this minority report to influence the decision,” he stated.

Less than two weeks later, on May 23, 2005, fifty-one members of congress sent a letter to Dara Corrigan, Acting Principal Deputy Inspector General at the Department of Health and Human Services requesting an investigation of the FDA’s request for a opinion from Dr Hager during consideration of Barr’s application to allow OTC sales of Plan B.

After an investigation, the Government Accountability Office said the decision not to approve Plan B was highly unusual, made with atypical involvement from high level FDA officials, and likely was made months before the formal announcement.

On May 30, 2005, as Paul Harvey would say, The Nation magazine published “the rest of the story,” in an article titled, “Dr. Hager’s Family Values,” by Ayelish McGarvey, which stated in part:

“In both his medical practice and his advisory role at the FDA, his ardent evangelical piety anchors his staunch opposition to emergency contraception, abortion and premarital sex.

“Through his six books–which include such titles as Stress and the Woman’s Body and As Jesus Cared for Women, self-help tomes that interweave syrupy Christian spirituality with paternalistic advice on women’s health and relationships–he has established himself as a leading conservative Christian voice on women’s health and sexuality.”

However, Linda Carruth Davis, co-author of, Stress and the Woman’s Body, is Dr Hager’s former wife of 32 years, and told the Nation that her ex-husband’s public moralizing on sexual matters clashed with his deplorable treatment of her during their marriage.

In the article, Ms Davis revealed that Dr Hager had repeatedly sodomized her without her consent for years. “I probably wouldn’t have objected so much, or felt it was so abusive if he had just wanted normal sex all the time,” she explained to Ms McGarvey.

“But it was the painful, invasive, totally nonconsensual nature of the sex that was so horrible,” Ms Davis said.

For seven years, she told the Nation, Dr Hager sodomized her while she slept, roughly once a month until their divorce in 2002. Sometimes, Ms Davis said, she fought him off and he would quit for a while, only to circle back later that same night, and at other times, she would just try and get it over with.

At other times, she said, she attempted to avoid his predatory advances by sleeping in other rooms, or trying to stay awake until he was asleep, but nothing worked.

According to Ms McGarvey, “As disturbing as they are on their own, Linda Davis’s allegations take on even more gravity in light of Hager’s public role as a custodian of women’s health.”

“Some may argue that this is just a personal matter,” she wrote, “between a man and his former wife–a simple case of “he said, she said” with no public implications.”

“That might be so,” she continued, “if there were no allegations of criminal conduct, if the alleged conduct did not bear any relevance to the public responsibilities of the person in question, and if the allegations themselves were not credible and independently corroborated.”

“But given that this case fails all of those tests,” Ms McGarvey states, “the public has a right to call on Dr. David Hager to answer Linda Davis’s charges before he is entrusted with another term.”

“After all,” she correctly points out, “few women would knowingly choose a sexual abuser as their gynecologist, and fewer still would likely be comfortable with the idea of letting one serve as a federal adviser on women’s health issues.”

The day after the Nation published the story, Dr Hager resigned stating: “I will no longer be on the advisory committee after June 30.”

According to Ms McGarvey, Ms Davis had told a handful of people about the abuse during her marriage, and several longtime confidantes confirmed that she had told them at the time it was occurring. Ms Davis’ attorney and a close friend of 25-years also spoke to Ms McGarvey on the record, and several others spoke to her off the record.

As for Dr Hager, he told the reporter, “My official comment is that I decline to comment.”